Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Number of Participants With Serious and Non-serious Adverse Events Spontaneously Reported by Subject and/or Observed by Investigator. [ Time Frame: Screening (Day -5 for continuous cardiac monitoring) to Day 22 ]

N100 auditory evoked potential response (amplitude measured in microvolts) using the sensory gating paradigm. Measured by electroencephalography (EEG) as the amplitude ratio of test stimulus to conditioning stimulus. Plotted on a unitless scale of 0 to 2. Normalization is suggested by a lower value.

Time Frame

Days -1 to 20

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Subjects providing valid and measurable N100 responses.

Reporting Groups

Description

Placebo

Matching placebo was administered as one capsule per day for 21 days.

EVP-6124 (1.0 mg/Day)

EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.

EVP-6124 (0.3 mg/Day)

EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.

Measured Values

Placebo

EVP-6124 (1.0 mg/Day)

EVP-6124 (0.3 mg/Day)

Number of Participants Analyzed
[units: participants]

2

5

5

N100 Gating Ratio
[units: ratio]Mean ± Standard Error

1.648
± 0.29

0.801
± 0.19

0.951
± 0.20

Statistical Analysis 1 for N100 Gating Ratio

Groups [1]

Placebo vs. EVP-6124 (1.0 mg/Day)

Method [2]

ANCOVA

P Value [3]

=0.10

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

Baseline value was the covariate and all values obtained during the treatment period were averaged together. This value was adjusted by regression against the baseline and estimation of a new value as if all subjects possessed the same baseline.

[2]

Other relevant method information, such as adjustments or degrees of freedom:

No text entered.

[3]

Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance: